Diabetes mellitus, often referred to as diabetes, is a chronic condition in which a person has elevated blood glucose levels that result from defects in the body's ability to produce and/or use insulin. There are three main types of diabetes. Type 1 diabetes usually strikes children and young adults, and may be autoimmune, genetic, and/or environmental. Type 2 diabetes accounts for 90-95% of diabetes cases and is linked to obesity and physical inactivity. Gestational diabetes is a form of glucose intolerance diagnosed during pregnancy and usually resolves spontaneously after delivery.
In 2009, according to the World Health Organization, at least 220 million people worldwide suffer from diabetes. In 2005, an estimated 1.1 million people died from diabetes. Its incidence is increasing rapidly, and it is estimated that between 2005 and 2030, the number of deaths from diabetes will double. In the United States, nearly 24 million Americans have diabetes with an estimated 25 percent of seniors age 60 and older being affected. The Centers for Disease Control and Prevention forecast that 1 in 3 Americans born after 2000 will develop diabetes during their lifetime. The National Diabetes Information Clearinghouse estimates that diabetes costs $132 billion in the United States alone every year. Without treatment, diabetes can lead to severe complications such as heart disease, stroke, blindness, kidney failure, amputations, and death related to pneumonia and flu.
Management of diabetes is complex as the level of blood glucose entering the bloodstream is dynamic. Variation of insulin in the bloodstream that controls the transport of glucose out of the bloodstream also complicates diabetes management. Blood glucose levels are sensitive to diet and exercise, but also can be affected by sleep, stress, smoking, travel, illness, menses, and other psychological and lifestyle factors unique to individual patients. The dynamic nature of blood glucose and insulin, and all other factors affecting blood glucose, often require a person with diabetes to forecast blood glucose levels. Therefore, therapy in the form of insulin or oral medications, or both, can be timed to maintain blood glucose levels in an appropriate range.
Management of diabetes is often highly intrusive because of the need to consistently obtain reliable diagnostic information, follow prescribed therapy, and manage lifestyle on a daily basis. Daily diagnostic information, such blood glucose, is typically obtained from a capillary blood sample with a lancing device and is then measured with a handheld blood glucose meter. Interstitial glucose levels may be obtained from a continuous glucose sensor worn on the body. Prescribed therapies may include insulin, oral medications, or both. Insulin can be delivered with a syringe, an ambulatory infusion pump, or a combination of both. With insulin therapy, determining the amount of insulin to be injected can require forecasting meal composition of fat, carbohydrates and proteins along with effects of exercise or other physiologic states. The management of lifestyle factors such as body weight, diet, and exercise can significantly influence the type and effectiveness of a therapy.
Management of diabetes involves large amounts of diagnostic data and prescriptive data that are acquired from medical devices, personal healthcare devices, patient recorded information, healthcare professional tests results, prescribed medications and recorded information. Medical devices including self-monitoring blood glucose (bG) meters, continuous glucose monitors, ambulatory insulin infusion pumps, diabetes analysis software, and diabetes device configuration software each of which generates or manages or both large amounts of diagnostic and prescriptive data. Personal healthcare devices include weight scales, and blood pressure cuffs. Patient recorded information includes information relating to meals, exercise and lifestyle. Healthcare professional biomarker data includes glycated hemoglobin (HbA1C), cholesterol, triglycerides, and glucose tolerance. Healthcare professional recorded information includes therapy and other information relating to the patient's treatment.
There are times in which the diabetes patient may wish to perform personal glucose testing in low light conditions. For instance, the patient may want to perform the test in a dark or poorly lit room. Because the test requires a certain amount of precision (e.g., proper placement of a blood droplet on the dosing area of a test strip), it can be difficult to complete the test in such conditions. Thus, there is a need for a handheld diabetes management device for providing enhanced illumination in such situations.
There is a need for a handheld patient device to aggregate, manipulate, manage, present, and communicate diagnostic data and prescriptive data from medical devices, personal healthcare devices, patient recorded information, biomarker information and recorded information in an efficient manner to improve the care and health of a person with diabetes, so the person with diabetes can lead a full life and reduce the risk of complications from diabetes.
Additionally, there is a need to provide such a handheld patient device that can offer touch screen convenience while still meeting regulatory (such as Food and Drug Administration) cleaning requirements. Furthermore, there is a need to provide an internal component configuration that can optimize the internal space of the handheld device.
There is a need for a handheld patient device to aggregate, manipulate, manage, present, and communicate diagnostic data and prescriptive data from medical devices, personal healthcare devices, patient recorded information, biomarker information and recorded information in an efficient manner to improve the care and health of a person with diabetes, so the person with diabetes can lead a full life and reduce the risk of complications from diabetes.
It will also be appreciated that at the present time, patients with diabetes may be asked to periodically assess their daily glycemic control, for example by conducting a three day blood glucose (bG) test. This involves the patient checking his/her bG several times during consecutive twenty four hour periods and manually recording the data in a chart. Preferably, the three day bG test is done with the patient checking his/her bG levels at seven different times during the day: 1) pre-breakfast; 2) post-breakfast; 3) pre-lunch; 4) post-lunch; 5) pre-dinner; 6) post-dinner; and 7) bedtime. The results of each of the bG tests may be recorded manually by the patient. The bG tests need to be performed within the context for each of the above-described seven events (which may include a predetermined time window). As will be appreciated, this can be somewhat of a burdensome procedure for the patient. It is also important that the patient record all of the obtained bG information correctly on the three-day bG test chart. The information must be accurately and legibly recorded on the chart, typically using a writing implement such as a pencil or pen. Thus, while carrying out the three day bG profile the user is typically required to carry a pencil or pen with him or her as well as the bG testing supplies, which as will be appreciated may cause a degree of inconvenience to the user. Typically the user must carry, in a purse or pocket, the paper chart for recording the bG test values, which may also add some inconvenience to the user. Finally, it is important that the user not misplace or otherwise damage the paper chart while carrying out the test, lest important bG test information becomes unavailable or unreadable, thus requiring the test to be started over. Automating the three day bG profile through a handheld device that can be carried more easily on the person of a user would significantly reduce the possibility of a paper chart being lost, misplaced or otherwise damaged to the point where the data recorded thereon is unreadable.
Further to the above, individuals with diabetes often may need to perform a series of paired glucose tests to help understand particular issues with behavior or therapy. This test involves having an individual obtain pairs of bG values before and after various events. For example, an individual can obtain a bG value before a specific meal, for example before lunch, and another bG value within a specified time after the lunch meal. The “before” and “after” bG values form a related “pair” of bG values and can be used as data for a “Testing In Pairs” (TIPs) test. Collecting and reviewing a plurality of related pairs of before/after bG test data for various events throughout the day (e.g., breakfast, lunch, dinner), while considering the type of food that was consumed at each meal, may help give the individual a better idea of how his/her bG levels are affected by certain foods or events, and thus may help the individual to better manage her/his bG levels throughout the day.
The above described TIPs test, however, can be somewhat inconvenient for an individual to carry out manually. The paired bG values need to be manually recorded by the individual such as by writing down the results in a log. This must be done typically for each meal of the day, and then compiled in such a way that the recorded results are able to show the individual how the bG test values changed throughout the day in response to the meals that the individual consumed. Often an external computer may be needed to present the bG test results in a fashion that aids in understanding the test results. Moreover, the individual must be attentive to the time periods during which the “before” and “after” bG test values must be obtained. Missing a “before” meal bG test will prevent the use of an “after” meal bG test result, for the purpose of constructing a “pair” of bG values for the test.
Additionally, there is a need for a handheld diabetes management device that is able to provide an even more accurate bolus recommendation to the user based on various user inputs that take into account current activities and a current health of the user, and which is also highly customizable by the user to thus enhance the accuracy, convenience and efficiency of the device in generating a recommended bolus or a suggested carbohydrate amount for the user.
There is a need for a patient to be able to manage, manipulate and control the desired range of blood glucose levels over a period of time through a hand-held device in an efficient manner to improve the care and health of a person with diabetes, so the person with diabetes can lead a full life and reduce the risk of complications from diabetes.
Management of diabetes involves large amounts of diagnostic data and prescriptive data that are acquired from medical devices, personal healthcare devices, patient recorded information, healthcare professional tests results, prescribed medications and recorded information. Clinicians generally treat diabetic patients according to published therapeutic guidelines such as, for example, Joslin Diabetes Center & Joslin Clinic, Clinical Guideline for Pharmacological Management of Type 2 Diabetes (2007) and Joslin Diabetes Center & Joslin Clinic, Clinical Guideline for Adults with Diabetes (2008). The guidelines may specify a desired biomarker value, e.g., a fasting blood glucose value of less than 100 mg/dl, or the clinician can specify a desired biomarker value based on the clinician's training and experience in treating patients with diabetes. However, such guidelines do not specify biomarker collection procedures for parameter adjustments to support specific therapies used in optimizing a diabetic patient's therapy. Subsequently, diabetic patients often must measure their glucose levels with little structure for collection and with little regard to lifestyle factors. Such unstructured collection of glucose levels can result in some biomarker measurements lacking interpretative context, thereby reducing the value of such measurements to clinicians and other health care providers. Thus, there is a need to provide structured collection procedures for diagnostic or therapy support of a patient with diabetes or other chronic diseases.
Patients with diabetes and their healthcare professionals interact with a variety of medical devices and systems to help manage the disease, including performing structured collection procedures. For each of these differing types of medical devices, there is a need to aggregate, manipulate, manage, present, and communicate diagnostic data and prescriptive data from multiple data sources in an efficient manner to improve the care and health of a person with diabetes, so the person with diabetes can lead a full life and reduce the risk of complications from diabetes. There is also a need to aggregate, manipulate, manage, present, and communicate such diagnostic data and prescriptive data amongst the different types of medical devices using a standard communication protocol. IEEE 11073 is an exemplary communication standard that addresses interoperability and communication amongst medical devices such as blood pressure monitors, blood glucose monitors and the like. Within the context of such communication protocol, there is a further need to support the structured collection procedures implemented by the medical devices.
When designing an overall system for diabetes management or an application residing on a given medical device in the system, there is a further need to identify and implement extension points in the system to support future growth.
Additionally, since the handheld device is battery powered, there is a need to effectively manage power consumption of the handheld device to optimize operating times between battery recharges. Specifically, there is a need to control the power consumption by selectively disabling one or more components of the handheld device based on the usage and internal temperature of the handheld device. Further, the handheld device measures blood glucose levels by performing chemical analysis of samples deposited on a strip, which is inserted into a port of the handheld device. Since chemical processes used in the chemical analysis are sensitive to temperature, there is a need to monitor internal temperature of the handheld device, estimate an ambient temperature proximate to a reaction site on the strip based on the internal temperature, and selectively disable one or more components of the handheld device based on the ambient temperature.
Additionally, to effectively manage the care and health of the patient, there is a need for the handheld device to store the diagnostic and prescriptive data on a database on the handheld device. A technical problem arises, however, when the database is stored on a nonvolatile solid-state memory, as the risk of a database failing increases. Thus, there is a need to reliably store medically important data in a database on a handheld device.
The design and manufacture of such handheld devices may occur in multiple jurisdictions and different standards may apply for different components of the handheld device. For instance, regulatory agencies in Europe and the United States may impose different standards for radio communications, medical devices, and other areas. Thus, there is a need for well-defined interfaces in the core of the handheld device that allow for modularity when integrating different components in the handheld device, such that the core functionality of the handheld device does not need to be modified depending on the components of the device.
Consequently, there is a need for a handheld patient device that offers connectivity with a wide range of other devices, including healthcare devices, computers, consumer electronics, and accessories. There exists a need for a handheld patient device that serves as a hub for a patient's diabetes management, from glucose monitoring to insulin infusion to historical tracking. There exists a need for such a handheld patient device so that patients and clinicians will have more information to monitor and manage diabetes, thereby making diabetes management less intrusive and more appealing to the patient.
Consequently, there is a need for a handheld patient device that can be upgraded, both to add new features and improve patient interfaces, and to implement required improvements, such as regulatory requirements, business rule updates, and fixes. In order to reduce the burden on doctors' offices and to be more convenient for patients, there is a need for a handheld patient device that can be upgraded without requiring a clinic visit. However, there is a need for the upgrade process to require little or no computer expertise. Especially for upgrades that will not be performed at a clinic, there is a need for the upgrade process to be reliable so as to avoid compromising the function of the handheld patient device.
Additionally, to effectively manage the care and health of the patient, there is a need for the handheld device to communicate with other medical devices and systems. The other medical devices and systems, however, may use different communication protocols and interfaces (e.g., Bluetooth protocol, universal serial bus (USB) interface, etc.). Accordingly, there is a need for the handheld device to include multiple communication protocols and interfaces that enable the handheld device to communicate with the other medical devices and systems in a safe and secure manner. Additionally, to manage coexistence of multiple communication interfaces in the handheld device, there is a need for techniques to decrease probability of collisions and interference between communications performed by the multiple communication interfaces. Further, to minimize the size of the handheld device, two or more communication interfaces may be integrated into a single integrated circuit (IC) and may share an antenna so that additional communication interfaces and corresponding antennas can be added to the handheld device. Sharing an antenna also requires implementing prioritization and arbitration schemes to effectively communicate with the medical devices.
Additionally, to effectively manage the care and health of the patient, there is a need for the handheld device to communicate with other medical devices and systems, as well as for those other medical devices and systems to communicate. In order to communicate securely and reliably, the handheld device may need to establish a secure communication link between itself and the other medical devices and systems. Such a process may require a user (such as a patient with reduced visual acuity and/or technical skill) to follow a complex procedure that requires extensive user input. Additionally, in order for those other medical devices and systems to communicate between themselves securely and reliably, each device/system may need to establish a secure communication link between itself and the other medical devices and systems. To establish each such communication link, a user (such as a patient with reduced visual acuity and/or technical skill) may have to perform a complex procedure that requires extensive user input, which is inefficient subject to error. Accordingly, there is a need for a method of establishing a secure communication link between a handheld device and other medical devices/systems that is relatively simple and reduces the number and complexity of user inputs. Further, there is a need for a handheld device and/or diabetes management system that reduces the number and complexity of user inputs to utilize and establish secure communication links between a handheld device and various other devices that allows the various other devices to securely communicate without directly establishing a secure communication link between themselves.
Additionally, to effectively manage the care and health of the patient, there is a need for the handheld device to communicate with other medical devices and systems. In order to communicate securely and reliably, the handheld device may need to establish a secure communication link between itself and the other medical devices and systems. Such a process may require a user (such as a patient with reduced visual acuity and/or technical skill) to follow a complex procedure that requires extensive user input. Accordingly, there is a need for a method of establishing a secure communication link between the handheld device and other medical devices/systems that is relatively simple and reduces the number and complexity of user inputs. Further, there is a need for a diabetes management system that reduces the number and complexity of user inputs to utilize and establish a secure communication link between various devices.
Additionally, to effectively manage the care and health of the patient, there is a need for a means to reliably manage data records from the other medical devices. As the system of devices communicating with one another becomes more complex, a technical problem arises in trying to keep data records consistent, especially when patients are provided with the ability to enter and edit records manually. Accordingly, a system for tagging records with metadata that ensures unique metadata tags is described herein. Based on metadata tagging scheme, data records transmitted between the devices may remain consistent and confusion of data can be avoided.
Additionally, there is a need for a handheld diabetes management device that is able to provide an even more accurate bolus recommendation to the user based on various user inputs that take into account current activities and a current health of the user, and which is also highly customizable by the user to thus enhance the accuracy, convenience and efficiency of the device in generating a recommended bolus or a suggested carbohydrate amount for the user.
The background description provided herein is for the purpose of generally presenting the context of the disclosure. Work of the presently named inventors, to the extent it is described in this background section, as well as aspects of the description that may not otherwise qualify as prior art at the time of filing, are neither expressly nor impliedly admitted as prior art against the present disclosure.